The EUA will continue to cover adolescents 12 through 15 years of age and the administration of a third dose to certain immunocompromised individuals 12 years of age and older. Additionally, for logistical reasons, the EUA will continue to cover the use of the Pfizer-BioNTech COVID 19 Vaccine in individuals 16 years of age and older; this use is also now approved.“
Sorry, FDA, you are lying in the prior sentence. A vial of vaccine is either approved (licensed) or authorized under EUA. It cannot be both, unless the licensed drug/vaccine is being used off-label. In fact, you pointed out that the vaccine under EUA, compared to the fully approved, licensed vaccine, was “legally distinct.” And in the paragraph below you contradict yourself, saying providers can use the EUA vaccine as if it was approved. A licensed vaccine, being used for the purpose for which it was licensed, is not supposed to get an EUA liability waiver. It’s one more scam.–Nass
How is Comirnaty (COVID-19 VACCINE, mRNA) related to the PFIZER-BIONTECH COVID-19 VACCINE?
The FDA-approved Pfizer-BioNTech product Comirnaty (COVID-19 Vaccine, mRNA) and the FDA-authorized Pfizer-BioNTech COVID-19 Vaccine under EUA have the same formulation and can be used interchangeably to provide the COVID-19 vaccination series without presenting any safety or effectiveness concerns. Therefore, providers can use doses distributed under EUA to administer the vaccination series as if the doses were the licensed vaccine. For purposes of administration, doses distributed under the EUA are interchangeable with the licensed doses. The Vaccine Information Fact Sheet for Recipients and Caregivers provides additional information about both the approved and authorized vaccine.”